According to the World Health Organization (WHO), one third of the world�s population don�t have the necessary\r\naccess to pharmaceutical products, including essential drugs. In Brazil, the Governmental Health System (SUS)\r\ndistributes some medicaments for free to the population. They were, then, classified into three categories in the\r\ncountry: basic, strategic and specialized components. Among these categories, the last one is highlighted due\r\nto the expensive costs of its products, which are essential for the treatment of rare and specific diseases. For\r\nthis reason, the Ministry of Health created, in 1993, the Program for Specialized Medicaments, where all the\r\ndrugs included in this category were distributed for free through Clinics and Hospitals. During the first year of this\r\nProgram�s implementation, there were 15 different items distributed into 31 distinct presentations. Nowadays, the list\r\nexpanded to 150 different items dispensed into 310 presentations. Hence, the availability of imported pharmaceutical\r\nproducts in Brazil overloaded the expenses by the Brazilian Ministry of Health. Only during 2011, US$ 1.5 billion\r\nwere spent on these products, where 30% of this amount was related to specialized ones. In order to reduce costs,\r\nthe Brazilian Federal Government developed, in 2004, the Technological Innovation Law. According to the Decree\r\nnumber 6.041, the National Politics for Biotechnology and the National Committee of Biotechnology were created\r\nin order to stimulate the development of Biotechnology for human health, targeting mainly the national production\r\nof biopharmaceuticals. Furthermore, the end of patents for several medicaments during the last 5 years enhanced\r\nthe motivation for national production of new drugs. In this way, some Governmental Institutions, in partnership\r\nwith International Pharmaceutical Industries, started developing the first biosimilar molecules. Therefore, this report\r\ndescribes the evolution of Biotechnology in Brazil, relating the laws, regulations and Programs created along the last\r\n20 years for Human Health application.
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